This invention relates to the electrical stimulation of tissue for the treatment of selected physiological conditions and, more particularly, to a novel electrical stimulation apparatus and method having an interchangeable electrode module, the electrode module serving as an activation key and being preprogrammable to deliver a predetermined treatment protocol for the particular physiological condition.
Various skin lesions such as those resulting from acne and herpes virus are known to be amenable to treatment through the use of electrical stimulation. Although various theories have been advanced to explain this phenomena, to date, no satisfactory explanation has been put forth as a rationale for why these types of skin conditions can be successfully treated using electrical stimulation. In spite of this lack of explanation, various devices have been developed for the delivery of electrical stimulation to tissue. For example, U.S. Pat. No. 5,117,826 teaches a device for the combined nerve fiber treatment and body stimulation while U.S. Pat. No. 5,133,352 teaches a method for treating herpes simplex. A small size, low frequency curing apparatus is shown in U.S. Pat. No. 4,922,906. An electrotherapeutic treatment apparatus is shown in U.S. Pat. No. 5,107,835. U.S. Pat. No. 4,913,148 discloses the treatment of herpes simplex I and II as well as herpes zoster. A low frequency electrotherapeutic device is disclosed in U.S. Pat. No. 5,133,351.
Each of these devices apparently resulted from the search for a device that could be used for the various therapeutic purposes as disclosed in the description of the device and its intended use. It is clear from the foregoing that electrical stimulation can be beneficial if appropriately applied to the area requiring treatment. Appropriate application includes, for example, predetermining the correct voltage of the electrical stimulation, the pulse waveform, if any, the amperage, and the application duration, to name several. Clearly, each application requires that each of the foregoing elements of the electrical stimulation must be tailored to meet the specific requirements for each patient.
In view of the foregoing, it would be an advancement in the art to provide an electrical stimulation apparatus and method wherein the apparatus is preprogrammable to provide each patient with the appropriate electrical stimulation as a function of the patient condition to be treated. It would also be an advancement in the art to provide the electrical stimulation apparatus with a replaceable electrode module. It would be an even further advancement in the art to provide the electrode module with a logic circuit to allow the electrode module to be preprogrammed with the predetermined operating parameters for the electrical stimulation apparatus. It would be an even further advancement in the art to provide an electrical stimulation apparatus that provides both the patient and the treating physician with the capability of monitoring treatment progress with the electrical stimulation apparatus. Such a novel invention is disclosed and claimed herein.
A novel electrical stimulation apparatus having a hand-held housing and a replaceable electrode module is provided as well as a method of treatment. The housing includes a first electrical circuit and a first battery for the operation of the electrical stimulation function by alternating monopolar bursts of current. A second electrical circuit and second battery provides a time/date function. A key in the electrode module enables energization of the aforementioned first electrical circuit. A liquid crystal display (LCD) on the housing is coupled to both the first and second electrical circuits and provides a visual display of the various functions of the electrical stimulation apparatus including a treatment timer, an ON/OFF indicator, a battery status indicator, an indicator for the number of remaining treatments available, a screen prompt, a treatment indicator, treatment cycle indicator, an audio indicator (beeper), visual bars, and a time/date display, respectively. The electrode module is provided with a programmable probe control logic to allow the electrical stimulation apparatus to be selectively programmed for each particular application.
The present apparatus and method are particularly well suited for the treatment of herpes simplex and herpes zoster. For this purpose, the apparatus is programmed to apply seriatim a pair of alternating monopolar bursts of current to a skin region to be treated. The monopolar bursts of current can have a current intensity of up to about 30 milliamperes and a duration of about 10 seconds each. Preferably a time interval of about one second at no current flow (i.e., a current intensity of zero) is maintained between the monopolar bursts of alternating polarity.
In general, the prescribing physician prescribes the appropriate treatment protocol which is entered into the programmable probe control logic of the electrode module. The patient obtains the preprogrammed electrode module under prescription and plugs it into the hand-held housing where the preprogrammed prescription is relayed to the first electrical circuit in the housing. The operating instructions to commence the treatment protocol are visibly displayed on the LCD to instruct the patient in the operation of the stimulation apparatus. Importantly, the electrode module is specifically programmed to meet the treatment requirements of the individual patient during the treatment process and, equally importantly, the electrode module is programmed to cease functioning upon completion of its programmed treatment cycle. This latter feature is designed to encourage the patient to return to the prescribing physician for further analysis of the patient""s condition and thereby enable the physician to selectively alter the treatment protocol as programmed into the electrode module in order to more suitably treat the patient.